A Study of SKB571 in Participants With Gastrointestinal Tumors

August 2, 2026 updated by: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with gastrointestinal tumors. Approximately 120 subjects will be enrolled in this study, including 4 cohorts with approximately 20-30 participants enrolled in each cohort.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Principal Investigator:
          • Li Zhang
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Yigui Chen
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Principal Investigator:
          • Jiayi Li
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Principal Investigator:
          • Ruihua Xu
      • Guangzhou, Guangdong, China, 510655
        • Not yet recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Yanhong Deng
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Yuhua Cao
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Jian Shi
        • Principal Investigator:
          • Fengbin Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Tumor Hospital of Harbin Medical University
        • Principal Investigator:
          • Yanqiao Zhang
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Jun Yao
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Ruihua Zhao
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Yan Zhao
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Zhenyang Liu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Principal Investigator:
          • Xia He
        • Principal Investigator:
          • Sheng Li
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Yanhong Gu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Anwen Liu
        • Principal Investigator:
          • Hua Wang
      • Nanchang, Jiangxi, China, 3300029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Principal Investigator:
          • Huiqing Zhang
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • Wei Li
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Jinglei Qu
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Hui Guo
        • Principal Investigator:
          • Xiaoran Guo
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Principal Investigator:
          • Lei Cong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Principal Investigator:
          • Changzheng Li
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Xiuying Xiao
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Hongxia Lu
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Principal Investigator:
          • Yongdong Jin
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Principal Investigator:
          • Ting Deng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
  2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.
  3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Life expectancy ≥ 12 weeks as assessed by the investigator.
  6. Adequate organ and bone marrow function.
  7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
  8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion Criteria:

  1. Participants with other malignant tumors within 3 years before the first dose of study treatment.
  2. History or current metastases to central nervous system.
  3. Current uncontrolled concomitant diseases
  4. Clinically severe lung damage due to complications of lung disorder
  5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
  6. A history of severe skin diseases
  7. Unresolved toxicity from prior anti-tumor therapy
  8. Serious infection within 4 weeks before the first dose of study treatment
  9. Known active pulmonary tuberculosis.
  10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  12. Pregnant or breastfeeding women.
  13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Oesophageal Squamous Cell Carcinoma (ESCC)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Colorectal Adenocarcinoma (CRC)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Safety and tolerability
Time Frame: Up to approximately 24 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Up to approximately 24 months
Immunogenicity
Time Frame: Up to approximately 24 months
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Time Frame: Up to approximately 24 months
Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma
Up to approximately 24 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Time Frame: Up to approximately 24 months
Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma
Up to approximately 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between biomarkers and efficacy
Time Frame: Up to approximately 24 months
To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SKB571-II-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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